UMIN-CTR Clinical Trial

Basic information
Public title	Neural correlates of pain relief by tactile stimulation: An MEG study
Acronym	Neural correlates of pain relief by tactile stimulation: An MEG study
Scientific Title	Neural correlates of pain relief by tactile stimulation: An MEG study
Scientific Title:Acronym	Neural correlates of pain relief by tactile stimulation: An MEG study
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the differences between the pain and tactile processing and clarify mechanism of the pain relief by tactile stimulation using MEG
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	source location, amplitude and waveform
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	pain by intra-epidermal electric stimulation mechanical tactile stimulation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy volunteers with written informed consent
Key exclusion criteria	1. history of neurological conditions or chronic pain. 2. current or prior history of traumatic events or surgery involving the right arm 3. on any medication
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shozo Middle name Last name Tobimatsu
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Clinical Neurophysiology
Zip code	8128582
Address	3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL	092-642-5541
Email	tobi@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Mariko Middle name Last name Hayamiu
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Clinical Neurophysiology
Zip code	8128582
Address	3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL	092-642-5541
Homepage URL
Email	hayamizu@med.kyushu-u.ac.jp

Sponsor
Institute	Department of Clinical Neurophysiology, Neurological Institute, Faculty of Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Institute
Department

Funding Source
Organization	Grant-in-aid for Scientists from the Ministry of Education, Culture, Sports, Science, and Technology in Japan.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Ethical Comitte
Address	3-1-1 Maidashi Higashi-ku Fukuoka city Fukuoka
Tel	092-642-5774
Email	byskenkyu@jimu.kyushu-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 30 Day

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/abs/pii/S1053811916000951
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S1053811916000951
Number of participants that the trial has enrolled	11
Results	Source localization using minimum norm estimates demonstrated that pain-related activity was located in the posterior insula, whereas tactile-related activity was estimated in the parietal operculum. Significant inhibition of pain-related activity in the posterior insula due to cortical modulation. Spinal modulation was observed both in the posterior insula and parietal operculum. Subjective pain, as evaluated by the visual analog scale, also showed significant reduction in both conditions.
Results date posted	2022 Year 06 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Eleven healthy right-handed volunteers participated in this study. The subjects had no history of neurological conditions or chronic pain. They also had no current or prior history of traumatic events or surgery involving the right arm, and were not on any medication.
Participant flow	Written informed consent was obtained from all subjects.
Adverse events	None
Outcome measures	Brain activity related to noxious and tactile stimulation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 14 Day
Date of IRB	2015 Year 09 Month 13 Day
Anticipated trial start date	2015 Year 09 Month 14 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 30 Day
Last modified on	2022 Year 06 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023089